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From natural extract
to hemi-synthetization
Homoharringtonine has been known for 20 years for its remarkable clinical activities in the treatment of myeloid leukaemia.
This molecule originally used the natural extract of cephalotaxus species.
How was the activity
of homoharringtonine demonstrated ?
The activity of homoharringtonine was demonstrated through more than 50 clinical studies, mainly sponsored by the National Cancer Institute in the USA, and from China, where the cephalotaxus originally comes from.
More than 1’200 patients received homoharringtonine in published phase I or phase II trials for leukaemia.
List of publications
The efficacy described in these studies concern the homoharringtonine used either as a single agent or as a combined agent. Its specific mechanism of action and the absence of cross resistance with other commonly used agents offers a wide range of combination therapies with a promising synergetic effect.
Why natural homoharringtonine has not been registered so far ?
Despite its clinical efficacy, homoharringtonine has not been registered simply because the natural extract formulations raised several unresolved difficulties, such as:
• The product reproduction in an identical manner
• Purity profile
• Single source of raw material from China
• Biodiversity preservation issues
The hemi-synthetization of homoharringtonine
In 1998 the hemi-synthetization process was successfully developed by direct attachment to the chiral side chain.
The hemi-synthetization of homoharringtonine lifted technical barriers to a registration by solving production, reproducibility, and purity issues.
It also brought an answer to biodiversity preservation problems.
The Myelostat®, or hemi-synthetic homoharringtonine Stragen, was developed for iv or sub-cutaneous administration
Stragen Pharma has started the Myelostat® registration program including the clinical studies in chronic and acute myeloid leukemias
Patents
Stragen is the sole owner of the hemi-synthetis process of homoharringtonine.
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